Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mirador Biomedical, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112203 | COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS | Mirador Biomedical, Inc. | 2011-12-14 | 135 | 0 |
| K103715 | COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / IN | Mirador Biomedical, Inc. | 2011-01-20 | 30 | 0 |
| K101518 | COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE | Mirador Biomedical, Inc. | 2010-10-13 | 133 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda